RecruitingNot ApplicableNCT05599061

Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial

Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Randomized Trial

Sponsor

Fundación EPIC

Enrollment

600 participants

Start Date

Jan 30, 2023

Study Type

INTERVENTIONAL

Conditions

Coronary Disease Coronary Artery Disease Ischemic Heart Disease

Summary

The study aims to compare a preventive percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) strategy vs. OMT for treatment of non-functionally significant non-culprit lesions presenting with optical coherence tomography (OCT) findings indicative of vulnerable plaque, in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether treating vulnerable (potentially unstable) but non-obstructive coronary plaques with stents reduces the risk of future heart attacks in patients who had a heart attack (STEMI) and also have other areas of narrowing in their arteries. After treating the main blocked artery, researchers will use special imaging to identify and treat these at-risk plaques in other vessels. You may be eligible if: - You are over 18 years old - You had a heart attack (STEMI) and the main blocked artery was successfully opened within 72 hours - You have additional coronary artery narrowings of 40-69% in other vessels suitable for assessment - You have signed informed consent You may NOT be eligible if: - You are a woman of childbearing potential (under 50, still menstruating) who has not had sterilization surgery - You have a known intolerance to aspirin, heparin, everolimus, or contrast dye - You have cardiogenic shock or unresolved mechanical complications - You have severe kidney dysfunction (creatinine clearance <45 mL/min) - You have asthma or bronchial hyper-reactivity - You are currently participating in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERFFR>0.80+ OCT with findings indicative of vulnerable plaque

Patients received OPTIMAL MEDICAL TREATMENT (OMT)+PCI

OTHERFFR>0.80+ OCT with findings indicative of vulnerable plaque

OPTIMAL MEDICAL TREATMENT (OMT)

Locations(49)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario A Coruña

A Coruña, Spain

Hospital General Universitario de Albacete

Albacete, Spain

Hospital General Universitario Dr.Balmis

Alicante, Spain

Hospital Universitari Sant Joan D'Alacant

Alicante, Spain

Hospital Universitari Germans Trias I Pujol

Badalona, Spain

Hospital Del Mar

Barcelona, Spain

Hospital de Santa Creu I Sant Pau

Barcelona, Spain

Hospital Universitari Vall Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario Puerta Del Mar

Cadiz, Spain

Hospital General Universitario de Castellón

Castellon, Spain

Hospital General Universitario de Ciudad Real

Ciudad Real, Spain

Hospital Universitario Reina Sofia de Cordoba

Córdoba, Spain

Hospital General Universitario de Elche

Elche, Spain

Hospital Universitario de Cabueñes

Gijón, Spain

Hospital Universitario de Girona Dr Trueta

Girona, Spain

Hospital Universitario San Cecilio

Granada, Spain

Chu de Toledo

Guadalajara, Spain

Hospital Universitario Juan Ramon Jimenez

Huelva, Spain

H.U. de Gran Canaria-Dr. Negrin

Las Palmas de Gran Canaria, Spain

H.I.U. Materno Infantil de Las Palmas

Las Palmas de Gran Canaria, Spain

Hospital Universitario de Leon

León, Spain

Hospital La Princesa

Madrid, Spain

Hospital Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Spain

Hospital de Manises

Manises, Spain

Hospital de Merida

Mérida, Spain

Hospital Universitario Virgen Arrixaca

Murcia, Spain

Hospital Universitario Central de Asturias

Oviedo, Spain

Hospital Universitari Son Espases

Palma de Mallorca, Spain

Hospital Universitario de Navarra

Pamplona, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

Hospital Universitario de Donostia

San Sebastián, Spain

Hospital Universitario Nuestra Señora de La Candelaria

Santa Cruz de Tenerife, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Hospital Universitari Joan Xxiii

Tarragona, Spain

Hospital Universitari MútuaTerrassa

Terrassa, Spain

Hospital Universitario de Torrevieja

Torrevieja, Spain

Hospital Universitario 12 Octubre

Usera, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital General Universitario de Valencia

Valencia, Spain

Hospital Universitari I Politecnic La Fe

Valencia, Spain

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Spain

Hospital Universitari Miquel Servet

Zaragoza, Spain

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NCT05599061

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